Expects to Initiate the Phase 2 Expansion
Study in the Second Half of 2024
Acclaim-3 Study Supported by FDA Orphan Drug
and Fast Track Designations
AUSTIN,
Texas, May 14, 2024 /PRNewswire/ -- Genprex, Inc.
("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene
therapy company focused on developing life-changing therapies for
patients with cancer and diabetes, today announced that the first
patient has been enrolled and dosed in the Company's Phase 1 dose
escalation portion of the Acclaim-3 clinical study of Reqorsa®
(quaratusugene ozeplasmid) Immunogene Therapy in combination
with Genentech's Tecentriq® to treat patients with
extensive-stage small cell lung cancer (ES-SCLC).
"We are excited to take this next step in our fight against lung
cancers as we work to advance an innovative therapy that we believe
provides hope to patients suffering with ES-SCLC, an especially
aggressive form of lung cancer that has extremely limited treatment
options," said Ryan Confer,
President and Chief Executive Officer at Genprex. "With a median
progression free survival (PFS) of 5.2 months, ES-SCLC has a
particularly poor prognosis. Additionally, patients receiving
Tecentriq as maintenance therapy have a median PFS of 2.6 months
after the start of maintenance therapy. With such limited benefit
from current treatments, we believe the combination of REQORSA and
Tecentriq can provide a promising new therapeutic option for the
treatment of small cell lung cancer."
"The Phase 1 dose escalation portion of the Acclaim-3 study is
expected to determine the maximum tolerated dose for the Phase 2
expansion study," stated Mark
Berger, M.D., Chief Medical Officer of Genprex. "The
favorable results from our Phase 1 Acclaim-1 study in non-small
cell lung cancer (NSCLC) enabled us to shorten the Phase 1 portion
of Acclaim-3. This should allow us to complete the Phase 1 portion
of the study during the second half of 2024 and to advance more
quickly into the Phase 2 expansion portion of Acclaim-3 in the
second half of 2024. We look forward to providing study updates as
we advance this potentially life-saving therapy to benefit patients
battling ES-SCLC."
Genprex has a novel cancer treatment platform that re-expresses
tumor suppressor genes in cancers. Tumor suppressor genes are often
deleted or inactivated early in the process of cancer development.
REQORSA contains a plasmid that expresses TUSC2, a tumor suppressor
gene protein. Nearly 100% of SCLCs have reduced or no TUSC2 protein
expression, and 41% completely lack TUSC2 protein expression.
Nonclinical studies in mice support the hypothesis that
re-expressing the TUSC2 protein may lead to improved clinical
efficacy in combination with Tecentriq.
About the Acclaim-3 Clinical Trial
The Acclaim-3
clinical trial is a Phase 1/2 open-label, dose escalation and
clinical response study of maintenance therapy evaluating REQORSA
in combination with Tecentriq in patients with ES-SCLC. The
Acclaim-3 clinical trial will enroll patients who did not develop
tumor progression after receiving Tecentriq and chemotherapy as
standard initial treatment, and who are therefore eligible for
maintenance therapy.
The Phase 1 dose escalation portion of the Acclaim-3 clinical
study is expected to enroll up to 12 patients at approximately ten
U.S. clinical sites to determine the Maximum Tolerated Dose (MTD).
If no dose limiting toxicities occur during the Phase 1 study, the
highest dose evaluated will be the Recommended Phase 2
Dose. The Phase 2 portion of the study is expected to enroll
approximately 50 patients at ten to fifteen U.S. sites. Patients
will be treated with REQORSA and Tecentriq until disease
progression or unacceptable toxicity is experienced. Genprex
expects to initiate the Phase 2 expansion study in the second half
of 2024.
The primary endpoint of the Phase 2 portion of the trial is to
determine the 18-week progression-free survival rate from the time
of the start of maintenance therapy with REQORSA and Tecentriq
treatment in patients with ES-SCLC. Patients will also be followed
for survival. A Phase 2 futility analysis will be performed after
the 25th patient enrolled and treated
reaches 18 weeks of follow up.
Genprex has received U.S. Food and Drug Administration (FDA)
Ophran Drug and Fast Track designations for Reqorsa® Immunogene
Therapy, in combination with Genentech, Inc's Tecentriq® in
patients with ES-SCLC who did not develop tumor progression after
receiving Tecentriq and chemotherapy as initial standard treatment.
Additional information about the Acclaim-3 clinical trial can be
found by visiting ClinicalTrials.gov.
About Reqorsa® Immunogene Therapy
Reqorsa®
(quaratusugene ozeplasmid) Immunogene Therapy for NSCLC and SCLC
consists of the TUSC2 gene expressing plasmid encapsulated in
non-viral nanoparticles made from lipid-based molecules in a
lipoplex form (Genprex's Oncoprex® Delivery System) with a positive
electrical charge. REQORSA is injected intravenously and
specifically targets cancer cells, which generally have a negative
electrical charge. REQORSA is designed to deliver the functioning
TUSC2 gene to cancer cells while minimizing their uptake by normal
tissue. REQORSA has a multimodal mechanism of action whereby it
interrupts cell signaling pathways that cause replication and
proliferation of cancer cells, re-establishes pathways for
programmed cell death, or apoptosis, in cancer cells, and modulates
the immune response against cancer cells. In addition, REQORSA
disrupts the metabolism of cancer cells by decreasing glycolysis
and ATP production in cancer cells with decreased TUSC2.
Genprex's strategy is to develop REQORSA in combination with
currently approved therapies and believes that REQORSA's unique
attributes position it to provide treatments that improve on
current therapies for patients with NSCLC, SCLC, and possibly other
cancers.
Tecentriq® is a registered trademark of Genentech, Inc.
About Genprex, Inc.
Genprex, Inc. is a clinical-stage
gene therapy company focused on developing life-changing therapies
for patients with cancer and diabetes. Genprex's technologies are
designed to administer disease-fighting genes to provide new
therapies for large patient populations with cancer and diabetes
who currently have limited treatment options. Genprex works with
world-class institutions and collaborators to develop drug
candidates to further its pipeline of gene therapies in order to
provide novel treatment approaches. Genprex's oncology program
utilizes its systemic, non-viral Oncoprex® Delivery System which
encapsulates the gene-expressing plasmids using lipid-based
nanoparticles in a lipoplex form. The resultant product is
administered intravenously, where it is taken up by tumor cells
that then express tumor suppressor proteins that were deficient in
the tumor. The Company's lead product candidate, Reqorsa®
(quaratusugene ozeplasmid) Immunogene Therapy, is being evaluated
in three clinical trials as a treatment for NSCLC and SCLC. Each of
Genprex's three lung cancer clinical programs has received a Fast
Track Designation from the FDA for the treatment of that patient
population, and Genprex's SCLC program has received an FDA Orphan
Drug Designation. Genprex's diabetes gene therapy approach is
comprised of a novel infusion process that uses an AAV vector to
deliver Pdx1 and MafA genes directly to the pancreas. In models of
Type 1 diabetes, GPX-002 transforms alpha cells in the pancreas
into functional beta-like cells, which can produce insulin but may
be distinct enough from beta cells to evade the body's immune
system. In a similar approach, GPX-002 for Type 2 diabetes, where
autoimmunity is not at play, is believed to rejuvenate and
replenish exhausted beta cells.
Interested investors and shareholders are encouraged to sign up
for press releases and industry updates by visiting
the Company Website, registering for Email
Alerts and by following Genprex on Twitter, Facebook and
LinkedIn.
Cautionary Language Concerning Forward-Looking
Statements
Statements contained in this press release
regarding matters that are not historical facts are
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. These forward-looking
statements are made on the basis of the current beliefs,
expectations and assumptions of management, are not guarantees of
performance and are subject to significant risks and uncertainty.
These forward-looking statements should, therefore, be considered
in light of various important factors, including those set forth in
Genprex's reports that it files from time to time with the
Securities and Exchange Commission and which you should review,
including those statements under "Item 1A – Risk Factors" in
Genprex's Annual Report on Form 10-K for the year ended
December 31, 2023.
Because forward-looking statements are subject to risks and
uncertainties, actual results may differ materially from those
expressed or implied by such forward-looking statements. Such
statements include, but are not limited to, statements regarding:
Genprex's ability to advance the clinical development,
manufacturing and commercialization of its product candidates in
accordance with projected timelines and specifications; the timing
and success of Genprex's clinical trials and regulatory approvals;
the effect of Genprex's product candidates, alone and in
combination with other therapies, on cancer and diabetes; Genprex's
future growth and financial status, including Genprex's ability to
maintain compliance with the continued listing requirements of The
Nasdaq Capital Market and to continue as a going concern and to
obtain capital to meet its long-term liquidity needs on acceptable
terms, or at all; Genprex's commercial and strategic partnerships,
including those with its third party vendors, suppliers and
manufacturers and their ability to successfully perform and scale
up the manufacture of its product candidates; and Genprex's
intellectual property and licenses.
These forward-looking statements should not be relied upon as
predictions of future events and Genprex cannot assure you that the
events or circumstances discussed or reflected in these statements
will be achieved or will occur. If such forward-looking statements
prove to be inaccurate, the inaccuracy may be material. You should
not regard these statements as a representation or warranty by
Genprex or any other person that Genprex will achieve its
objectives and plans in any specified timeframe, or at all. You are
cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date of this press release.
Genprex disclaims any obligation to publicly update or release any
revisions to these forward-looking statements, whether as a result
of new information, future events or otherwise, after the date of
this press release or to reflect the occurrence of unanticipated
events, except as required by law.
Genprex, Inc.
(877) 774-GNPX (4679)
GNPX Investor
Relations
investors@genprex.com
GNPX Media Contact
Kalyn
Dabbs
media@genprex.com
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